Medical lead and method for medical lead manufacture

ABSTRACT

A lead employing a connection between a conductor and an electric element is provided. The connection includes a conductive pad electrically connected to at least one conductor and the electric element electrically connected to the conductive pad. The conductive pad can further include an elongated element to connect the pad to the electric element. The method for connecting a conductor to an electric element is also provided. The method includes forming a groove in the insulator of a lead body to expose the conductor. Placing a conductive pad within the groove and electrically connecting a conductive pad to the conductor. An electric element is then placed over the conductive pad and the electric element is electrically connected to the conductive pad.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a medical leads and particularly to amethod of medical lead manufacture and medical leads having a conductivepad connecting a band electrode to a conductor.

2. Description of the Related Art

Implantable leads form an electrical connection between a pulsegenerator or other electronic device and a tissue or structure in thebody. For example, leads transmit electric signals used to stimulatecardiac or nerve tissue in one direction and signals generated bysensors placed in proximity to particular organs or tissues in theopposite direction. Leads typically include one or more electrodes atthe lead's distal end. The electrodes are designed to form an electricalconnection with a tissue or organ. Most leads also include a leadconnector at the lead's proximal end. Lead connectors are adapted toelectrically and mechanically connect leads to the pulse generators orother electronic medical devices. A conductor connects the electrode tothe lead connector. Commonly, the conductor takes the form of a singleor multifilar wire coil. Although, there is an increasing interest inusing stranded cables as conductors. Regardless of the conductor's form,an insulating material typically surrounds the conductors. Spinal chordstimulation leads are typically formed with individually insulatedconductors surrounded by a separate lead body tube. Together, theconductor and the insulating material form the lead body. The lead bodycouples the lead connector at the proximal end with the electrode at thedistal end.

Manufacturing leads is costly. A significant portion of the cost isallocated to electrically connecting the conductors to the variouselectrodes, sensors and connectors used in the industry. Forming asecure electrical junction has proven difficult and time consuming.Laser welds are commonly used to connect the conductors to theelectrodes. The conductors are typically helically wound into a coil forincreased reliability and flexibility. Band electrodes are typicallyconnected to conductors by welding in an operation separate from theapplication of the lead body tube. Once the band electrodes areconnected to the conductors, an extruded tube is placed over theconductor coil and welded band electrodes are connected to the lead bodytube by insert molding or RF welding. Band electrodes may also beconnected to a conductor by etching away a region of insulator, applyinga coating of electrically conductive adhesive, and then placing the bandelectrode around the conductor. This etching method is complex, notamenable to automation and expensive. Therefore, a need exists for amethod that reduces complexity and is easily automated to reduceproduction costs.

In another method of attachment, band electrodes are electricallyconnected to coiled conductors by placing a soft metal in a hole cutinto an insulating sleeve. An electrode is placed over the metal andcrimped or swaged to bring the electrode, soft metal and coiledconductors into electrical contact and to secure the electrode to thelead body. The crimping or swaging method of connection results inelectrical connections between the conductor and the band electrode thatmay fail. Further, swaging to electrically connect an electrode to aconductor is time consuming and difficult to implement with the modernreduced diameter leads. Hence, a need exists for an improvedmanufacturing technique to secure band electrodes to conductors thatreduces the time, complexity and cost while increasing reliability.

In addition, current manufacturing techniques frequently require addingelements, such as collars, when connecting a band electrode to a coil.The added elements increase the lead's diameter near the weld. Inapplication, a uniform diameter weld would result in a smaller lead. Asmaller diameter lead is desired to allow placement in restricted spacessuch as the epidural space or cardiac veins to reduce the effects ofimplanted lead on the patient. Further, a smaller lead allows for asmaller introducer that reduces the trauma associated with implantationand similarly a smaller removal sheath when explanting the lead. Hence,there exists a need to reduce the diameter of the welds used to secureelectrodes to conductors in implantable medical leads.

The present invention meets these needs and provides other advantagesand improvements that will be evident to those skilled in the art.

SUMMARY OF THE INVENTION

The present invention provides a lead and method for lead constructionthat reduces the time, complexity and costs of producing implantableelectrical leads by providing a novel connection between the conductorsand an electrode, connector or sensor.

The medical lead includes a lead body, a conductive pad and a band. Thelead body is comprised of an insulator and at least one conductor. Theinsulator includes at least one welding region exposing at least oneconductor. The welding region may be in the form of a groove cut in theinsulator. When in the form of a groove, the welding region typically iscut parallel to the orientation of the conductor. The conductive pad issecured within the welding region to electrically connected to theconductor to the pad. The conductive pad may be composed of stainlesssteel, MP35N, platinum, gold, silver, copper, vanadium or other metal.The conductive pad may be electrically connected to the conductor bywelding, conductive adhesives, crimping or other methods. Alternative tothe conductive pad, an elongated conductive element may be used toelectrically connected to the conductor to the pad. The elongatedconductive element can be a wire, a ribbon wire, a cable, or otherelongated form. The elongated conductive element may be composed ofstainless steel, MP35N, platinum, gold, silver, copper, vanadium orother metal. The elongated conductive element may be electricallyconnected to the conductor by welding, conductive adhesives, crimping orother methods. The band is welded to the conductive pad to electricallyconnect the band to the conductor. The band may be a band electrode, aband connector, a sensor, or other element electrically secured tomedical leads. The band may include a plurality of projections on aninner wall of a lumen. The projections space the inner wall from anouter surface of the lead body. Three or more projections may bepositioned around the inner wall to center the lead body within thelumen during assembly.

The method for manufacturing a medical lead includes forming a weldingregion, securing a conductive pad within the welding region, andsecuring a band to the conductive pad. The welding region is typicallyformed by cutting through the insulator to expose the conductor. Thewelding region can cut with a laser, typically an excimer laser, or canbe mechanically cut. The conductive pad is secured within the weldingregion adjacent the conductor. The conductive pad can be secured withinthe welding region using a weld, crimping conductive adhesives or othermethod. The band is secured to the conductive pad to electricallyconnect the band to the conductor. To secure the band, a weld is formedbetween the conductive pad and the band. A yttrium-arsenic-garnet lasermay be used to form the weld.

Alternatively to the use of a conductive band, an elongated conductiveelement may be substituted. The proximal end of the elongated conductiveelement is secured conductor within the welding region. The band is thenpositioned around the lead body and over the welding region. The distalend of the elongated conductive element is then electrically connectedto the band. The elongated conductive element may be electricallyconnected to the band by welding.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a lead in accordance with thepresent invention;

FIG. 2 illustrates a longitudinal cross-sectional view of a of a leadshowing an embodiment of the connection between a coiled conductor and aband with a conductive pad;

FIG. 3 illustrates a top view of a lead, as shown in FIG. 2, without theband;

FIG. 4 illustrates a longitudinal cross-sectional view of a of a leadshowing the connection between a coiled conductor and a band with anelongated conductive element;

FIG. 5 illustrates a top view of a lead, as shown in FIG. 4, without theband;

FIG. 6A illustrates a cross-sectional longitudinal view of a bandelectrode, as shown in FIGS. 4 and 5; and

FIG. 6B illustrates and end view of the band electrode, as in FIG. 6A.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a medical lead and a method for leadmanufacture. The invention is described generally in the context of anelectrode for a neurostimulating lead and a method for manufacturing aneurostimulating lead as a specific example for illustrative purposesonly. The appended claims are not intended to be limited to any specificexample or embodiment described in this patent. It will be understood bythose skilled in the art that leads in accordance with the presentinvention may be used for a wide variety of applications including, butnot limited to, leads and catheters for use with cardiac monitoringdevices, cardiac rhythm management devices, ablation devices, mappingdevices, neurostimulating devices, neuromonitoring devices or othermedical devices using leads or catheters. Further, in the drawingsdescribed below, the reference numerals are generally repeated whereidentical elements appear in more than one figure.

FIG. 1 illustrates an embodiment of a lead 10 made in accordance withthe present invention. Leads designed for neurostimulation typicallyhave two or more longitudinally spaced band electrodes at the lead'sdistal end. Lead 10, as shown, includes a lead body 12 and four bandelectrodes 14. Lead 10 is generally configured to transmit an electricsignal from a pulse generator (not shown) to a spinal nerve orperipheral nerve. Thus, electrodes 14 are typically located at thedistal end of lead 10. Lead body 12 includes a flexible lead insulatorsurrounding one or more conductors. The conductors are electricallycoupled to the band electrodes. In addition, a lead connector 15 istypically located at the proximal end of lead body 12 to electricallycouple the conductors to the pulse generator.

Typically, lead body 12 is a flexible, elastomeric structure having around cross-section. Alternatively, lead body's cross-section could beany number of shapes appropriate for the specific application. Thefigures and the following description generally refer to roundcross-sectional shape for lead bodies for exemplary purposes. The leadinsulator is generally configured to insulate the conductors and topresent a smooth biocompatible external surface to body tissues. Thus,the lead insulator is typically coextensive with the conductor orconductors. When a plurality of conductors form a multipolar lead,individual conductors are typically electrically isolated from oneanother. The insulator material is typically selected based onbiocompatibility, biostability and durability for the particularapplication. The insulator material may be silicone, polyurethane,polyethylene, polyimide, polyvinylchloride, PTFE, ETFE, or othermaterials known to those skilled in the art. Moreover, alloys and blendsof these materials may also be formulated to control the relativeflexibility, torqueability, and pushability of the lead. Depending onthe particular application, the diameter of the lead body may be assmall as 2 French or smaller for neurological and myocardialmapping/ablation leads and can be sizes larger than 12 French for otherapplications.

The conductors may take the form of solid wires, drawn-filled-tube(DFT), drawn-brazed-strand (DBS), stranded cables or other forms thatwill be recognized by those skilled in the art. The conductors may becomposed of stainless steel, MP35N, or other conductive materials knownto those skilled in the art. The number, size, and composition of theconductors will depend on particular application for the lead.

At least one band electrode 14 is positioned at the distal end of leadbody 12 for electrically engaging a target tissue or organ. In addition,at least one band connector 15 is positioned at the proximal end of thelead body for electrically connecting the conductors to theneurostimulator. For purposes of the present invention, band electrodes14 and band connectors 15 are collectively referred to as bands. Thebands are typically made of a conductive material such as platinum,gold, silver, platinum-iridium, stainless steel, MP35N or otherconductive metals or alloys thereof known to those skilled in the art.The bands are typically composed of a material thin enough to allow forwelding of the elements to the underlying conductive pad, as discussedbelow. For neurostimulation, band electrodes 14 are typically between 1and 10 millimeters long and have a diameter between about 2 and about 8French but are more typically between 4 and 6 French. Typically, bandconnectors 15 have a size and configuration appropriate to connect thelead to a particular neurostimulator.

FIG. 2 illustrates the details of an embodiment of the connectionbetween a conductor 22 and band electrode 14 in accordance with thepresent invention. Band electrodes are the point of electrical contactbetween the conductors and the patient. Although discussed in thecontext of a band electrode, one skilled in the art will recognize thatthe following description is also applicable to a band connector, asensor or other electrical element. For exemplary purposes, bandelectrode 14 and lead body 12 is configured for two welds at a weldingregion 20. At least one weld is typically utilized. In the particularembodiment, the same conductor is connected to band electrode 14 twice.FIG. 2 illustrates a longitudinal cross-section of a lead body havingfour spirally wound conductors for exemplary purposes. The lead body isshown with four conductors. The conductors may be visible through theinsulating material when the insulating material is translucent.

FIG. 3 illustrates a top view of a lead body having the insulatingmaterial removed to form welding region 20 by exposing conductor 22.Welding region 20 provides access to conductor(s) 22 for electricallyconnecting the band electrode to conductor 22. Welding region 20 istypically formed by removing the insulating material from lead body 10.The insulating material is removed to expose small sections of theindividual conductors 22 without breaching an inner lumen, if present.Typically, an excimer laser is used to remove the insulating material.When the insulator is removed by laser, welding region 20 may be in theform of a groove in the insulator. Although, welding region 20 may takea variety of forms and orientations that expose a sufficient surfacearea of conductor 22 to form an electrical connection with a conductivepad, discussed below. When in the form of a groove, welding region 20 istypically formed such that the groove runs parallel to conductor 22.Regardless of the form of welding region 20, enough insulating materialis removed to expose sufficient surface area of conductor 22 forsecuring a conductive pad or elongated conductive element to theconductor.

Referring to FIGS. 2 and 3, a conductive pad 24 is positioned withinwelding region 20 during manufacture to facilitate the electricalconnection of band electrode 14 and conductor 22. A weld 26 is typicallyused to secure the conductive pad 24 in electrical contact withconductor 22. Alternatively, conductive pad 24 may be secured using anadhesive. Conductive pad 22 may be composed of any of a variety ofconductive materials that can be welded or secured with adhesives. Themetal may be stainless steel, MP35N, Pt—Ir, platinum, silver, gold,copper, vanadium or other metal that will be recognized by one skilledin the art upon review of this disclosure. Conductive pad 24 ispositioned within welding region 20 so that conductive pad 24 is inelectrical contact with conductor 22. Typically, conductive pad 24 iswelded to the conductor prior to placing band electrode 14 over thewelding regions and conductive pads 24. A pulsedNeodymium:yttrium-arsenic-garnet (YAG) laser may be used to weldconductive pad 24 to conductor 22. FIG. 2 shows a side view of across-section of two grooves 20 that expose two regions of the sameconductor 22. Conductive pads 24 are welded to conductor 22 withingrooves 20. Band electrode 14 is placed over lead body 12 of lead 10 andwelded to conductive pads 24, thereby securing band electrode 14 to leadbody 12 and electrically connecting conductor 22 and band electrode 14.Band electrode 14 may be further secured to lead body 12 by swaging,crimping and/or adhesives. Alternatively, the band electrode may besecured to the lead body by heating the lead body. Heating the lead bodystress-relieves the plastic increasing the outside diameter and securingthe band electrode over the lead body. In addition, heating the leadbody may be used to create a lead having a uniform diameter band andlead body.

FIGS. 4 and 5 illustrate the details of another embodiment of aconnection between conductor 22 and a band connector 15 in accordancewith the present invention. Band connectors are the point of electricalcontact between the medical device using the lead and the conductorswithin the lead. Although discussed in the context of a band connector,one skilled in the art will recognize that the following description isalso applicable to band electrodes, sensors or other electricalelements. An elongated conductive element 34 is used to electricallyconnect the band to conductor 22. The elongated conductive element maybe in the form of a wire, a ribbon wire, or a cable. The metal may bestainless steel, MP35N, Pt—Ir, platinum, silver, gold, copper, vanadiumor other metal that will be recognized by one skilled in the art uponreview of this disclosure. A distal end of elongated conductive element34 is electrically connected to band connector 15. Typically, theelectrical connection employs a weld 28, although a conductive adhesiveor other method of conductively attaching may be used. FIG. 4 shows alongitudinal cross-section of a lead body having four spirally woundconductors. One or more welding regions 20 are formed through theinsulating material by removing the insulating material from lead body10. Typically, the insulating material is removed with a laser. Theproximal end of elongated conductive element 34 is positioned withinwelding region 20 so that the proximal end is in electrical contact withconductor 22. Typically, the proximal end is secured to conductor 22prior to placing band connector 15 over lead body 12. Again, theproximal end is typically welded although a conductive adhesive or othermethod of conductively attaching the proximal end may be used. Theelongated conductive element 34 and attached proximal end are typicallyconfigured to allow band connector 15 to pass over elongated conductiveelement 34 during assembly. The distal ends of elongated conductiveelements 34 may then be electrically connected to band connector 15.

FIGS. 4 and 5 illustrate a single exemplary connection between conductor22 and band connector 15 by welds 26 and 28. Thus, FIG. 4 shows only onegroove 20 exposing conductor 22. The proximal end of elongatedconductive element 24 is positioned within groove 20 is welded toconductor 22. Band connector 15 is placed over lead body 12 and weldedto elongated conductive element 34, thereby electrically connectingconductor 22 and band connector 15. Band connector 15 may be furthersecured to lead body 12 by swaging, crimping, adhesives and/or insertmolding. In addition, swaging may reduce the outside diameter of leadconnector 15 to permit the manufacture of a lead of uniform diameter.Further, lead body 12 may be expanded by heating to create a uniformdiameter for lead connector 15.

FIGS. 6A and 6B illustrate an embodiment of a band which may be used inconjunction with the present invention. Although discussed in thecontext of a band connector, one skilled in the art will recognize thatthe following description is also applicable to band electrodes, sensorsor other electrical elements. Band connector 15 includes an inner wall42 defining a lumen 44. At least one projection 46 is formed on theinner wall 42. Projections 46 define a space between inner wall 42 andan outer surface of the lead body during assembly. Projections 46 may bemolded on the inner surface; formed by crimping the exterior surface ofthe band; or added as separate elements secured to the inner surface ofthe band. Projections 46 have a height 45 which defines the amount ofspace between the outer surface of the lead body and inner wall 42.Height 45 is generally selected to allow conductive pads 24 and/orconductive elements 34 to pass beneath the inner wall during assembly.Typically, three projections are provided at positions around thecircumference of band connector 15 to center band connector 15 over leadbody 12 during assembly. Centering band connector 15 so that height 45is substantially the same around the circumference of the lead bodyassures clearance of the conductive element during assembly.

1.-29. (canceled)
 30. A method for manufacturing a medical lead, the method comprising: cutting a welding region in a lead body to expose a conductor; securing a conductive pad within the welding region adjacent the conductor; and securing a band to the conductive pad to electrically connected the band to the conductor.
 31. A method in accordance with claim 30 wherein the conductive pad is secured within the welding region by a method selected from the group consisting of welding, crimping and adhesives.
 32. A method in accordance with claim 30 wherein the welding region is in the shape of a groove.
 33. A method in accordance with claim 32 wherein the groove is formed obliquely across the lead body and parallel to the conductor.
 34. A method in accordance with claim 32 wherein the welding region is formed using a laser.
 35. A method in accordance with claim 34 wherein securing the band further comprises welding the band to the conductive pad using a laser.
 36. A method of forming a medical lead, the method comprising: forming using a laser a first welding region within insulating material in a lead body to expose a first conductor; forming using a laser a second welding region within the insulating material in the lead body expose the first conductor; forming a first conductive pad within the first welding region and electrically connecting the first conductive pad to the first conductor; forming a second conductive pad within the second welding region and electrically connecting the first conductive pad to the first conductor; electrically connecting a first electrode to the first conductive pad; and electrically connecting the first electrode to the second conductive pad.
 37. A method in accordance with claim 36 wherein the first welding region and the second welding region are in the shape of a groove.
 38. A method in accordance with claim 37 wherein the grooves are formed obliquely across the lead body and parallel to the first conductor.
 39. A method in accordance with claim 34 wherein electrically connecting the first electrode to the first conductive pad further comprises welding the electrode to the first conductive pad, and electrically connecting the first electrode to the second conductive pad further comprises welding the electrode to the second conductive pad.
 40. A method in accordance with claim 36 wherein the first and second conductive material each comprise a conductive metal selected from the group consisting of stainless steel, MB35N, Pt—Ir, platinum, silver, gold, copper and vanadium.
 41. A method of forming a medical lead, the method comprising: forming a welding region within insulating material in a lead body of the medical lead to expose a conductor, the welding region having a shape of a groove and formed obliquely across the lead body and parallel to the conductor; placing a conductive pad within the welding region and securing the conductive pad to the conductor using a laser; and electrically connecting an electrode to the conductive pad.
 42. A method in accordance with claim 41 wherein the welding region is formed using a laser.
 43. A method in accordance with claim 42 wherein the conductive material comprises a conductive metal selected from the group consisting of stainless steel, MB35N, Pt—Ir, platinum, silver, gold, copper and vanadium.
 44. A method in accordance with claim 41 further comprising: forming a second welding region within the insulating material to expose the conductor, the second welding region having a shape of a groove and formed obliquely across the lead body and parallel to the conductor; placing a second conductive pad within the second welding region and securing the second conductive pad to the conductor using a laser; and electrically connecting the electrode to the second conductive pad. 